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A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

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Trial Profile

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2025

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At a glance

  • Drugs Bezafibrate/obeticholic acid (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Intercept Pharmaceuticals

Most Recent Events

  • 31 Oct 2025 Status changed from active, no longer recruiting to discontinued. Reason the study was stopped: Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.
  • 25 Sep 2025 Planned End Date changed from 1 Mar 2030 to 1 Oct 2025.
  • 25 Sep 2025 Planned primary completion date changed from 1 Jan 2029 to 1 Oct 2025.

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